NCT07285408Not yet recruiting
Sarcopenia and NMIBC Prognosis Study
Impact of Body Composition, Sarcopenia, Myosteatosis, and Nutritional Status on Recurrence and Progression in Patients With Non-Muscle-Invasive Bladder Cancer: A Prospective Observational Study
Source: ClinicalTrials.gov · Last updated 16 Dec 2025
Brief summary (registry, in English)
The goal of this observational study is to evaluate whether body composition abnormalities (sarcopenia, myosteatosis, and obesity) and nutritional status influence the risk of recurrence and progression in adult patients with non-muscle-invasive bladder cancer (NMIBC). The main questions it aims to answer are: Do sarcopenia, myosteatosis, obesity, or malnutrition increase the likelihood of NMIBC recurrence and progression? Can clinical, laboratory, and CT-derived body composition parameters serve as predictive biomarkers that improve individualized risk stratification? Participants will undergo routine clinical and radiologic assessments, including: * completion of the SARC-F and NRS nutritional screening questionnaires * anthropometric measurements (BMI, waist circumference) * laboratory evaluation including serum albumin and testosterone * CT-based assessment of skeletal muscle index (SMI) and muscle density (SMD) * standard TURBT and structured follow-up with cystoscopy, cytology, imaging, and clinical evaluations to document recurrence and progression.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 30 Nov 2025
- Start date
- 2 Mar 2026
- Primary completion date
- 12 Jul 2027
- Lead sponsor
- General Hospital Sveti Duh
- Diseases
- Bladder cancer
- NCT number
- NCT07285408
What you commit to
- Study type: Observational
- Planned participants: 150
- From 2 Mar 2026 to the primary completion date, 12 Jul 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Muscle-invasive bladder cancer (≥ T2) at diagnosis
- Contraindications to CT imaging (e.g., severe renal dysfunction, contrast allergy if contrast required)
- Any condition that, in the investigator's judgment, would interfere with participation or data integrity
Age
- Age under 18 years
Other
- Low-risk NMIBC, as defined by clinical guidelines
- Expected survival less than 3 months
- Inability or unwillingness to adhere to scheduled follow-up
Who the study is looking for
- Adults aged 18 years or older
- Histologically confirmed non-muscle-invasive bladder cancer (NMIBC) (Ta, T1, or CIS)
- Scheduled for transurethral resection of bladder tumor (TURBT) as part of standard care
- Able to undergo CT imaging required for assessment of skeletal muscle index (SMI) and skeletal muscle density (SMD)
- Completed preoperative clinical evaluation including: SARC-F, NRS, anthropometric measurements (BMI, waist circumference), serum albumin, and routine laboratory tests
- Able and willing to provide written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.